Last chance: let the FDA know why you want direct access to your own genome

Regular readers of this blog will be very familiar with the fledgling personal genomics industry, a diverse set of companies offering to sell you information about your ancestry and disease risk based on your DNA. They will also know that the field has been labouring under a cloud of regulatory uncertainty, since a horrendous Congressional hearing into the industry in July last year, followed by rumbling threats of an impending regulatory crackdown by the FDA.

While the shape of the FDA’s planned regulation is still very much unclear – if indeed there are any genuine plans beyond public grand-standing – the tone of the agency’s two-day public meeting in March (best summarised by Dan Vorhaus) gave us a hint: there’s a very real chance that the agency will attempt to force consumers to access “health-relevant” genetic interpretation through a clinician.

But most readers know my views. The main purpose of this post is to encourage readers to make their own opinions known to the FDA. Thanks to Dan Vorhaus, the agency reopened its period of public comment at the end of March. That means there’s an opportunity here for those of us who believe in the importance of direct access to our own genetic information to directly tell the FDA what we think of plans to inhibit this access: but you only have until Monday to submit your comments.

Note that (with some notable exceptions) no-one is arguing that the personal genomics industry should be entirely free of regulation; rather, we have consistently argued that what is needed is light-touch regulation to ensure the accuracy of raw results, to punish false claims and unethical advertising, and to promote full transparency from companies to allow consumers to make an informed choice. Heavy-handed action from the FDA will do more harm than good; but unless the FDA knows that there’s sufficient public support for personal genomics, they may well take that path – so let’s do our best to ensure there’s no doubt about that support.